[Premium Content] Are Supplements Safe?
Examine.com‘s Kamal Patel clears the air about why supplements aren’t as safe as we think.
It’s normal to assume that all dietary supplements are inherently healthy, but that’s not always the case. Because of the way they are advertised, it’s easy to forget that some supplements aren’t only ineffective, but with improper use, they can also be dangerous—and in some cases, fatal.
In the U.S., the Food and Drug Administration (FDA) is the governing body that oversees the regulation of dietary supplements. If a supplement has been reported to cause serious adverse effects or reactions, the FDA has the authority to pull it from the market. However, no safety testing or FDA approval is required before a company can market their supplement. Due to the United States Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements remain largely unregulated by the FDA. Despite this, a survey conducted by the trade association Council for Responsible Nutrition found that “85% of American adults…are con dent in the safety, quality, and effectiveness of dietary supplements.”Half of all U.S. adults have reportedly used one or more supplements in the past 30 daysClick To Tweet
Today, about half of all U.S. adults have reportedly used one or more supplements in the past 30 days. While the majority of Americans trust in their supplements, more than one-third have not told their physician about using them. As a result, there are numerous documented drug-supplement interactions ranging from the mild to severe.
WHO AND WHAT WAS STUDIED?
The authors of this study aimed to investigate how many cases are caused by improper supplement usage annually. Researchers looked at ten years of data (2004-2013) to estimate the adverse events associated with dietary supplements from 63 different U.S. hospitals.
More than 3,600 cases were identified within the predetermined ten-year period and overall, it was found that about 23,000 people go to the ER for supplement-related visits every year, with about 2,150 (9.4%) of these resulting in hospitalization. Some of the major findings are summarized in Figure 1.
Figure 2 shows age and supplement category-related results. About a quarter of ER visits involved people between the ages of 20 and 34, but people older than 65 were more likely to have a visit that resulted in hospitalization. Surprisingly, one-fifth of supplement-related ER visits were due to accidental ingestion by children. Unlike their highly regulated pharmaceutical counterparts, supplements are not required to come with labels warning of serious side effects or potential drug interactions, which can be a contributing factor to supplement-related ER visits.
While 23,000 annual supplement-related emergency visits may sound high, this is less than 5% of ER visits that are pharmaceutical interaction related. However, these ER admittance rates do not contradict the idea that dietary supplements are fundamentally healthy. It’s also worth noting that overall incidences of supplement-related ER visits have remained constant over time. No significant changes were detected between 2004 and 2013 when accounting for population increases.
THE BIG PICTURE
The supplement industry is the wild west of nutrition. DSHEA has hampered the FDA’s ability to adequately regulate supplements, leaving the supplement industry partially policed by itself. Need proof? If you’ve ever taken a supplement that makes a health claim, you may have encountered this statement on the label: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
While all ingredients must be declared on the label, there is little oversight to ensure that these ingredients are actually present in the supplement and at the doses that are advertised on the packaging. Under DSHEA, there is no requirement for companies to provide any data to the FDA showing that their supplement is safe and effective unless they are introducing a new or novel ingredient.
With this in mind, if you are currently taking or thinking about adding a supplement to your diet, be sure to notify your doctor. Supplements can interact with prescription medication or could exacerbate certain medical conditions. Warfarin (Coumadin) is a good example. It is a blood-thinning medication that can be prescribed to people at risk of forming blood clots. To ensure that the medication works properly, these patients are usually placed on a low vitamin K diet, as vitamin K plays an essential role in forming blood clots. If they do not disclose that they are taking a multivitamin with vitamin K, they could be putting themselves at risk for developing unwanted clots.
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